ERIMIA Cristina-Luiza1, DUMITRESCU Denisa Elena1*, MITITELU Magdalena2
1Ovidius University of Constanta, Faculty of Pharmacy, Campus Corp C, Constanta, ROMANIA
2Clinical Laboratory and Food Hygiene Department, Faculty of Pharmacy, ”Carol Davila” University of Medicine and Pharmacy, 6, Traian Vuia Street, 020956, Bucharest, ROMANIA
In the context in which an increasing number of nutritional products are placed on the internal market of the European Union in the form of nourishment that are a concentrated source of nutrients and are used to supplement their intake in the normal diet, this article examines the regulation of the internal market of food supplements.
At the same time, the article aims to address the degree of harmonization of Euroopean legislation in the field of nutritional supplements in order to strengthen the functioning of the internal market, by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade in these products.
Keywords: European Union legislation, food supplements, internal market, free movement of goods, mutual recognition
The global food supplement market was valued at US $ 123.324,7 million by the end of 2015 and is expected to represent US $ 252.142,1 million by 2025, reflecting an anual increase of 7.4 %. In terms of ingredients, the vitamins and minerals segment contributes significantly to the overall revenue of the food supplement market.
The international food supplement distribution network consists of pharmacies, drugstores, supermarkets, hypermarkets, retailers, gas stations, internet, door-to-door sales agents.
After the growing recognition of the role of nutrition in maintaining health, food supplements began to gain ground, so that the import, then the production and marketing of these products in Europe, experienced a real explosion. In this reality, the development of unanimous and viable legislation within the European Union has become a necessity.
In this context, the first piece of legislation adopted for food supplements at EU level was Directive 2002/46 / EC , in which a definition of these products was given for the first time.
Following the adoption of Directive 2002/46 / EC, both in the EU Member States and in other European countries, numerous legislative changes have taken place in the field of food supplements. At the same time, the Directive opened the way for discussions on pan-European acceptance of the definition and health requirements for nutritional supplements, on their labeling rules, as well as for the adoption of rules on traditional medicinal plants.
Directive 2002/46 / EC lays down specific rules for vitamins and minerals used as ingredients in food supplements and for nutritional supplements containing vitamins or minerals and other ingredients. There are also rules for nutrients other than vitamins and minerals or other substances with a nutritional or physiological effect, used as ingredients of nutritional supplements. Chemicals used as sources of vitamins and minerals and specific values corresponding to the maximum and minimum levels for vitamins and minerals present in food supplements are also covered by the regulations of the Directive.
It should also be noted that nutritional supplements also apply to all horizontal food regulations, including general food safety requirements, producer responsibilities, traceability obligations, the provision of information and the recall of harmful products . The rules on food preparation and hygiene based on the principles of hazard analysis and critical control points (HACCP)  also apply to food supplements, as well as those governing food labeling in order to adequately inform the consumer about the composition, properties and use of foodstuffs . Regulations on the use of nutrition and health claims, which must be authorized before they can be used , conditions for the use of additives , maximum levels for residues and contaminants [7,8], and on the approval of foodstuffs new , also applies to nutritional supplements.
Results and discussions
Since 2006 at EU level has been established a procedure to assess the safety of food and food ingredients already on the market . The procedure covered by Regulation (EC) 1925/2006 has already been applied to a number of additional food ingredients, such as those from Yohimbe and Ephedra. The safety of green tea, hydroxyanthracene and monacolin K derivatives  is currently being investigated in the procedure, and the outcome of this risk assessment could lead to a ban on use or the imposition of restrictive conditions of use.
At EU level, harmonized provisions on the composition of nutritional supplements are limited. In addition to a number of specific labeling requirements, Directive 2002/46/EC contains a list of nutrients and their chemical forms that can be used in nutritional supplements. Maximum levels and conditions of use for other substances, such as traditional medicinal plants, traditional herbal preparations and bioactive substances (eg lutein and glucosamine), are not harmonized and therefore fall under national legislation.
However, the Food Supplements Directive has achieved two major vbjectives, providing, first and foremost, a harmonized definition for food supplements, a definition that Member States must apply uniformly and treat products that meet the definition in the same way.
Referring to the second objective, the Directive allows Member States to implement only a notification procedure whereby nutritional supplements are reported to national authorities at the time of their placing on the market. It should be noted that most Member States have introduced such a notification requirement, and some Member States apply it as a marketing authorization procedure. However, in the absence of harmonized regulation at European Union level, some Member States did not consider it necessary to introduce a notification obligation, so that food supplements circulate in their territory without being subject to any notification or marketing authorization procedure.
The limited European harmonization of compositional requirements for nutritional supplements has clearly led to national regulations that differ considerably between Member States, not only in terms of design and scope, but also in terms vf content. There are positive and negative national lists, with permitted or prohibited ingredients, maximum levels, specific labeling requirements and other conditions of use. Often, on the grounds that they do not comply with their national requirements, Member States prevent access from supplements in another Member State, even if those products are legally present on those national markets. Due to these legislative discrepancies, the free movement of nutritional supplements in the European internal market is prevented.
The principle of free movement of goods in the internal market has its origins in the famous Cassis de Dijon judgment of the Court of Justice of 20 February 1979  and formed the basis for a new development in the internal market for goods. Although not initially explicitly mentioned in the case law of the Court of Justice, the free movement of goods is a fully recognized value today .
Although there are several judgments in the Court’s case law in breach of the principle of the free movement of goods, technical obstacles to the free movement of nutritional supplements in the internal market remain widespread. Obstacles arise when national authorities apply internal rules laying down requirements (concerning name, shape, size, weight, composition, presentation, labeling and packaging) that products from other Member States must meet in which nutritional supplements are traded legally. If these rules do not implement the secondary legislation of the European Union, they constitute technical obstacles, in which case Articles 34 and 36 TFEU apply . This applies even when those rules apply to all products, without distinction.
According to the principle of mutual recognition, different national technical regulations continue to coexist in the internal market. This principle implies that, regardless of technical variations between the various national rules applicable in the European Union, Member States of destination may not prohibit the sale in their territories of nutritional supplements which are lawfully marketed in another Member State, even if they have been produced in accordance with technical and quality standards different from those which domestic products must comply with.
The only exception to the principle of mutual recognition is restrictions justified on the grounds described in Article 36 TFEU (protection of public morality or public security, protection of health and life of humans, animals or plants, etc.), or on imperative grounds of general public interest recognized by the case law Vf the Court of Justice. Even in this situation, the restrictions imposed by the Member States must always be proportionate to the aim pursued.
In order to facilitate the application of the principle of mutual recognition, by establishing procedures to minimize the possibility of creating illegal obstacles to the free movement of goods that have already been lawfully traded in another Member State, the European Union has adopted Regulation (EC) no. 764/2008 . The main objective of the Regulation is to define the rights and obligations of national authorities and undertakings where the authorities intend not to apply mutual recognition and to refuse access to the market for a food supplement lawfully marketed in another Member State.
According to the regulation, the burden of proof lies with national authorities that intend to deny market access. National authorities must communicate in writing the exact reasons (technical and scientific) for the intention to refuse the product access to the national market, and the economic operator is given the legal opportunity to state his case and to present sound arguments to the competent authorities.
The Regulation also provides for the obligation to set up in each Member State a system of information points on non-harmonized products (including nutritional supplements), which provides information on the technical rules of the products and the implementation of the principle of mutual recognition by economic operators and competent authorities of other Member States.
The evaluation of the European Commission from April 2014 to May 2015  showed, on the one hand, that the principle of mutual recognition for products does not work properly and, on the other hand, that Regulation (EC) no. Regulation (EC) No 764/2008 had a limited effect in facilitating the application of the principle of mutual recognition to non-harmonized products . Thus, it was found that the procedural instruments and guarantees established by that Regulation did not fulfill their purpose of improving the implementation of the principle, there are still several problems with the implementation of the principle, and Regulation (EC) no. 764/2008, which had several shortcomings, was replaced by Regulation (EU) 2019/515 . The new regulation, adopted with a view to improving the functioning of the European Union’s internal market, ensures that existing rights and obligations deriving from the principle of mutual recognition are respected by both economic operators and national authorities and must not affect further harmonization of the conditions under which the goods are marketed, including food supplements.
As a general rule, despite the existence of national technical rules in the Member State of destination, according to the principle of mutual recognition in the non-harmonized field, nutritional supplements produced or lawfully marketed in another Member State have a fundamental right to free movement, guaranteed by TFEU.
By way of exception, provided that the principle of proportionality is complied with, nutritional supplements manufactured or lawfully marketed in another EU Member State do not benefit from the principle of mutual recognition, if the Member State of destination can demonstrate that it is essential to impose its own technical rules concerning the goods in question, citing the grounds set out in Article 36 TFEU, or the overriding requirements arising from the case-law of the Court.
While the principle of mutual recognition is applied by some Member States, in a number of other states it is proving to be much more difficult to implement and, in some cases, even impossible to apply. States which refuse to apply the principle of mutual recognition to food supplements use two main arguments in order to prevent their entry into their market: either they consider the product to be dangerous for health or to classify it as a medicine, and in this case they must harmonized legislation at European Union level applies to it.
For the refusal of mutual recognition only the argument that a food supplement is harmful to the consumer is acceptable. In this situation, the Member State must demonstrate, in solid terms, that such a risk exists and that this risk cannot be controlled by less restrictive measures, such as labeling. Usually, the arguments put forward by national authorities refusing mutual recognition are rather soft, and the product which does not conform into national law is most often the determining factor in demonstrating a safety concern and imposing restrictions. For this reason, companies often simply renounce the project or, if it is economically acceptable, adapt their production of food supplements to the applicable national requirements.
- ”Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, published in the Official Journal of the European Union, L 183/51 of 12.7.2002.
- Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, published in the Official Journal of the European Union L 31 of 1.2.2002.
- Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, published in the Official Journal of the European Union L 139 of 30.4.2004.
- Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, published in the Official Journal of the European Union L 304 of 22.11.2011.
- Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, published in the Official Journal of the European Union L 404 of 30.12.2006.
- Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, published in the Official Journal of the European Union L 354 of 31.12.2008, consolidated version of 25.03.2020.
- Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, published in the Official Journal of the European Union L 70 of 16.3.2005, consolidated version of 31.01.2020.
- Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs, published in the Official Journal of the European Union L 364 of 20.12.2006, consolidated version of 01.04.2020.
- Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, published in the Official Journal of the European Union L 327 of 11.12.2015.
- Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, published in the Official Journal of the European Union L 404 of 30.12.2006, consolidated version of 15.05.2019.
- Coppens, P. (2018). Food Supplements in the European Union: the Difficult Route to Harmonization. Botanicals and Maximum Levels. Regulatory Focus. July 2018. Regulatory Affairs Professionals Society, available at: https://www.raps.org/news-and-articles/news-articles/2018/7/food-supplements-in-the-european-union-the-diffic
- Case C-120/78 Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein. Judgment of the Court of 20 February 1979, European Court reports 1979, pp. 649.
- See, for example, Case C-110/05 Commission v Italy, Rep. 2009, pp. I-519, paragraph 34.
- Consolidated version of the Treaty on the Functioning of the European Union (TFEU), published in the Official Journal of the European Union C 326 of 26.12.2012.
- Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC, published in the Official Journal of the European Union L 218 of 13.8.2008.
- European Commission, Study commissioned to Technopolis Group (2015): ‘Evaluation of the application of the principle of mutual recognition in the field of goods,’ ENTR/172/PP/2012/FC – LOT 4 carried out between April 2014 and May 2015, available at: http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/index_en.htm.
- European Commission, Proposal for a Regulation of the European Parliament and of the Council on the mutual recognition of goods lawfully marketed in another Member State, Brussels, 19.12.2017, COM (2017) 796 final, available at: https://eur-lex.europa.eu/resource.html?uri=cellar:d47e2d52-e4b2-11e7-9749-01aa75ed71a1.0003.02/DOC_1&format=PDF
- Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008, published in the Official Journal of the European Union L 91 of 29.2.2019”.